Mabpharm's Biobetter (CMAB008) for Infliximab Receives NMPA's Approval in China
Shots:
- NMPA has granted approval to market infliximab biobetter in China. Sorrento holds exclusive commercial rights to Infliximab biobetter Ab outside of China and plans to file a BLA for the product in the US and EU in 2021
- Biobetters are drugs that have similar structure and properties to an innovator product but are enhanced to produce better outcomes. The biobetter Ab produced in CHO cells has demonstrated a better safety profile than the parent mouse cell produced product- while maintaining its efficacy profile
- The approval covers 6 autoimmune and inflammation indications. Sorrento plans to meet with regulatory agencies to determine the best path towards registration for the US and EU
| Ref: Sorrento | Image: Analyze Markets
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